Use of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap

NCT04254445 | Unknown

• 1 other identifier: 0009-19-TLV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients planned to undergo a pleural tap will get verbal explanation or watch a personalized guidance video in addition to verbal explanation. Questionnaires will be filled to assess the effect of the video training on understanding, cooperation and anxiety.

Conditions

Pleural Effusion; Pleural Effusion, Malignant; Pleural Pleurisy Effusion

Keywords

Personalized video training; Thoracocentesis; Pleural tap

Outcome Measures

Primary Outcomes (2)

• Fulfillment of need for information gap

  Improvement of subjective self-assessment of the patient's need of information on the tap procedure following the explanation received, based on the short form of the Quality from Patient Perspective (QPP) measurement. The improvement in the intervention arm will be compared to the one of the control arm

  30 minutes

• Assessment of Anxiety

  Delta of subjective self-assessment on his/her anxiety about the procedure, following the explanation received (using visual scale of 1-100, based on the Visual Analog Scale (VAS)). The reduction of anxiety in the intervention arm will be compared to the one of the control arm

  30 minutes

Secondary Outcomes (2)

• The need of an active role

  30 Minutes

• Confidence and Knowledge to take actions

  30 minutes

Study Arms (2)

Training video arm

EXPERIMENTAL

Patients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff

Other: Personalized training video

Verbal explanation arm

NO INTERVENTION

Patients will standard explanation about the procedure, provided by the medical staff

Interventions

Personalized training video OTHER

Using a few demographic and medical details of the patients, provided by the medical staff, the video generator will create a 2-minute personalized custom video, suitable to the age, gender, language, and medical condition of the patients. No identifying information will be used, to protect patient's privacy.

Training video arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients hospitalized in Internal medicine C and D, Tel-Aviv Sourasky Medical Centers
• Patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap
• Patients who can read and understand the questions
• Patients who were interested in participating in the clinical trial and signed an informed consent form

You may not qualify if:

• Minors \< 18 years of age
• Pregnant women
• Patients who cannot read and understand, at the discretion of the investigator
• Patients which their medical condition does not allow them to undergo the study procedure

Sponsors & Collaborators

• GistMed Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Pleural Effusion; Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Orit Neudorfer, MD

  GistMed Ltd.

  STUDY DIRECTOR

Central Study Contacts

Orit Neudorfer, MD

CONTACT

+972-54-8886421; orit.neudorfer@gmail.com

Ori Rogovsky, MD

CONTACT

+972-52-4266770; orirog@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: February 5, 2020
• Study Start: February 16, 2020
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)